Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study
1 other identifier
observational
30,283
1 country
29
Brief Summary
This registry aims to monitor the safety of Compound Kuh-seng Injection and to identify the potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2014
Longer than P75 for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 10, 2014
CompletedFirst Posted
Study publicly available on registry
September 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedOctober 10, 2018
October 1, 2018
3.8 years
September 10, 2014
October 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection
2 years
Secondary Outcomes (4)
The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection
2 years
The incidence of anaphylactic reaction to Compound Kuh-seng Injection
2 years
The incidence of new ADRs to Compound Kuh-seng Injection
2 years
The incidence of new SARs to Compound Kuh-seng Injection
2 years
Study Arms (1)
Compound Kuh-seng Injection
Compound Kuh-seng Injection will be given to the patients, and the investigators will record all the information including ADR, application of Compound Kuh-seng Injection and the combined medications, etc.
Interventions
Compound Kuh-seng Injection is a kind of natural compound injection extracted from Chinese herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae. The major bioactive ingredients include oxymatrine，sophocarpidine, matrine, flavonoid etc.
Eligibility Criteria
Patients who use Compound Kushen Injection in the monitoring hospitals
You may qualify if:
- Patients who use Compound Kushen Injection in the monitoring hospitals
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhong Wanglead
- Shanxi Zhendong pharmaceutical Co. LTD.collaborator
Study Sites (29)
HanDan Central Hospital
Handan, Hebei, 056001, China
Handan First Hospital
Handan, Hebei, 056002, China
Bai Qiu'en International Peace Hospital
Shijiazhuang, Hebei, 050082, China
Henan University Huaihe Hospital
Kaifeng, Henan, 475001, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471000, China
Luoyang Central Hospital Affiliated to Zhengzhou University
Luoyang, Henan, 471009, China
Xinxiang Central Hospital
Xinxiang, Henan, 453000, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453199, China
Xinyang Central Hospital
Xinyang, Henan, 464000, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450003, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
The First Hospital of Henan College of Traditional Chinese Medicine
Zhengzhou, Henan, 451199, China
Shandong Provincial Western Hospital
Jinan, Shandong, 250022, China
Qingdao Center Hospital
Qingdao, Shandong, 266031, China
Tai'an Central Hospital
Tai’an, Shandong, 271000, China
The 88th Hospital of People's Liberation Army
Tai’an, Shandong, 271002, China
People's Hospital of Xintai City
Tai’an, Shandong, 271200, China
Weifang No.2 People's Hospital
Weifang, Shandong, 261041, China
Weihai Municipal Hospital
Weihai, Shandong, 264299, China
Central Hospital of Zibo
Zibo, Shandong, 255020, China
Jincheng General Hospital
Jincheng, Shanxi, 048006, China
The Fourth People's Hospital of Linfen
Linfen, Shanxi, 041099, China
Traditional Chinese Hospital of Shanxi
Taiyuan, Shanxi, 030012, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 044099, China
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017, China
AVIC 363 Hospital
Chengdu, Sichuan, 610041, China
Teaching Hospital of Chengdu University of T.C.M.
Chengdu, Sichuan, 610072, China
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000, China
Tianjin medical university cancer institute & hosptial
Tianjin, Tianjin Municipality, 300060, China
Biospecimen
Serum will be retained from the patients who have the anaphylaxis after given the Compound Kuh-seng Injection and the other 4 matched patients who do not has the anaphylaxis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhong Wang, M.D.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
- PRINCIPAL INVESTIGATOR
Zhan-Yu Pan, Ph.D.
Tianjin medical university cancer institute & hosptial
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
September 10, 2014
First Posted
September 12, 2014
Study Start
September 1, 2014
Primary Completion
June 1, 2018
Study Completion
October 1, 2018
Last Updated
October 10, 2018
Record last verified: 2018-10